On April 7, 18, and 19, 2011, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 16551 Henry Road, Escalon, California. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our investigation of your operation. You can find the FD&C Act and its associated regulations on the Internet through links on FDA’s web page at www.fda.gov.

We found that you offered for sale an animal for slaughter as food that was adulterated. Under section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. § 342(a)(2)(C)(ii), a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe under section 512 of the FD&C Act, 21 U.S.C. § 360b. Further, under section 402(a)(4) of the FD&C Act, 21 U.S.C. § 342(a)(4), a food is deemed to be adulterated if it has been held under insanitary conditions whereby it may have been rendered injurious to health.

Specifically, our investigation revealed that on or about November 3, 2010, you sold a bob veal calf, identified with back tag (b)(4),for slaughter as food. On or about November 3, 2010, (b)(4),slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of gentamicin in the kidney tissue. FDA has not established a tolerance for residues of gentamicin in the edible tissues of cattle. The presence of this drug in edible tissue from this animal causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. § 342(a)(2)(C)(ii).

Our investigation also found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply.

For example, you failed to maintain complete treatment records. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the FD&C Act, 21 U.S.C. § 342(a)(4).

During our investigation you had several prescription new animal drugs at your dairy that you claimed to be using on your dairy cattle, for which you did not have valid prescriptions from your veterinarian. These new animal drugs included the following; Ceftiofur (b)(4),Oxytocin Injection (b)(4),Dexamethasone Solution (b)(4),and Dexamethasone Solution (b)(4).Your use of these prescription new animal drugs was not by or on the lawful written or oral order of a licensed veterinarian within the context of a veterinarian-client-patient relationship in violation of sections 512(a)(4) and (5) of the FD&C Act, 21 U.S.C. § 360b(a)(4) and (5). Because your use of these drugs was not by or on the lawful written or oral order of a licensed veterinarian you caused the drugs to be unsafe under section 512(a) of the FD&C Act, 21 U.S.C. § 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C Act, 21 U.S.C. § 351(a)(5).

We also found that you adulterated the new animal drugs Ceftiofur (b)(4),Dexamethasone Solution (b)(4),Penicillin G Procaine Injectable Suspension (b)(4),and Dexamethasone Solution (b)(4). Specifically, our investigation revealed that you did not use Ceftiofur (b)(4),Dexamethasone Solution (b)(4),and Penicillin G Procaine Injectable Suspension as directed by their approved labeling. Use of these drugs in this manner is an extralabel use. See Title 21, Code of Federal Regulations (C.F.R.), Section 530.3(a), 21 C.F.R. 530.3(a).

The extralabel use of approved animal or human drugs in animals is allowed under the FD&C Act only if the extralabel use complies with sections 512(a)(4) and (5) of the FD&C Act, 21 U.S.C. § 360b(a)(4) and (5), and 21 C.F.R. Part 530, including that the use must be by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship.

Our investigation found that you administered Penicillin G Procaine Injectable Suspension to your dairy calves and cows without following the dosage as stated in the approved labeling. In addition, our investigation found that you administered Ceftiofur (b)(4) to your dairy cows without following the indication for use as stated in the approved labeling, and you administered Dexamethasone Solution (b)(4) to your dairy cows without following the dose as stated in the approved labeling. Your extralabel use of Penicillin G Procaine Injectable Suspension, Ceftiofur (b)(4), and Dexamethasone Solution (b)(4) was not under the supervision of a licensed veterinarian in violation of 21 C.F.R. 530.11(a). Because your use of these drugs was not in conformance with their approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drugs to be unsafe under section 512(a) of the FD&C Act, 21 U.S.C. § 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C Act, 21 U.S.C. § 351(a)(5).

The above is not intended to be an all-inclusive list of violations. As a producer of animals offered for use as food, you are responsible for ensuring that your overall operation and the food you distribute is in compliance with the law.

You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.

You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.

Your written response should be sent to Darlene Almogela, Director, Compliance Branch, U.S. Food and Drug Administration, San Francisco District, at 1431 Harbor Bay Parkway, Alameda, California 94502. If you have any questions about this letter, please contact Compliance Officer Karen L. Robles at (916) 930-3674 extension 1114 or via e-mail at Karen.Robles@fda.hhs.gov.